TESA-LABTEC-GMBH

The German patch and oral thin film maker announces the completion of a
Pre-Approval Inspection (PAI) by the US Food and Drug Administration
(FDA) in February 2016.

During a total of 7 days of inspection, FDA visited both, the R&D site
in Langenfeld as well as the manufacturing facility in Hamburg, Germany.
FDA provided feedback with a short list of observations which tesa
Labtec takes seriously. At the conclusion of the inspections, the FDA
Investigator said that the initial conclusion was to approve the sites
for commercial activities. That conclusion must still be reviewed within
FDA. The company is responding promptly to the observations which the
Investigator raised.

“This FDA inspection demonstrates a significant milestone within our
plan to expand our business to the US market.” stated Dr. Ingo Lehrke,
Managing Director of tesa Labtec. “The inspection paves the way to the
US market for our customers’ transdermal patches and oral thin films and
certifies the high quality of our development and manufacturing
capabilities. This achievement was made possible through the dedication
of our talented staff.” Dr. Lehrke concluded.

The PAI was triggered by a customer’s ANDA filing for a transdermal
patch, which is manufactured by tesa and is designated for US
distribution.

About tesa Labtec GmbH

tesa Labtec offers the development and manufacture of film shaped dosage
forms (CDMO services) like transdermal and topical patches as well as
buccal or sublingual films. The business activities comprise formulation
development, scale up and manufacture of clinical trial supplies or
finished products under full cGMP conditions. Thereby tesa counts on its
proprietary technologies Transfilm®
, Rapidfilm®
and
Mucofilm®
. tesa Labtec is a wholly owned subsidiary of tesa
SE, a member of the Beiersdorf group of companies, and represents the
pharmaceutical business in a truly global family of companies.